Efficacy of Sternum Guard in Post Cardiac Surgery Patient

NCT05229276 | Completed

• 2 other identifiers: LB.02.01/VII/402/KEP.097/20191706100560
• Study Type: interventional
• Target: 414
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, single-blind, randomized parallel superiority trial comparing two groups; Sternum GuardTM as the treatment arm and Bone Wax as the active control group. Both investigated modalities are materials used during sternotomy for covering the sewn sternal edge. The primary outcomes of this study comprised of four parameters; namely surgical site infection (superficial or deep infection), sternal dehiscence, hemostatic effect, and surgeon's satisfaction rate. The first three primary outcomes were assessed during the operation, at the end of the hospital stay, 14 days, and 30-days postoperative.

Conditions

Coronary Artery Disease; Valvular Heart Disease; Congenital Heart Disease in Adolescence; Post Operative Wound Infection; Surgical Site Infection; Postoperative Hemorrhage

Keywords

Sternum Guard; Bone Wax; Median sternotomy; surgical site infection; operative blood loss

Outcome Measures

Primary Outcomes (3)

• Surgical site infection

  A surgical site infection is an infection occurring within 30 days after the operation and only involving the skin and subcutaneous tissue (superficial) or involving deep soft tissues (fibrous connective tissues and muscle layers) of the post-surgical incision wounds. Superficial surgical site infections is identified by at least one of the following: purulent drainage, organisms isolated from an aseptically-obtained culture of fluid or tissue from the surgical site, presence of signs or symptoms of infection: pain or tenderness, localised swelling, redness or heat, or diagnosis of SSI by the surgeon or attending physician. A deep incisional SSI is an infection appears to be related to the operative procedure and involves deep soft tissues which is indicated by either; purulent drainage, a deep incision spontaneously dehisces, an abscess, diagnosis of a deep incisional SSI by a surgeon or attending physician.

  within 30 days after the sternotomy surgery performed

• Haemostatic effect

  It will assess the quantity of blood lost from the sternal edges in Sternum GuardTM and Bone Wax group. The Sternum GuardTM and sterile drapes will be weighed before and after surgery to estimate the blood lost.

  immediately after the median sternotomy surgery finished

• Satisfaction rate

  A rating value from the surgeon as the user of the materials being investigated in terms of satisfaction upon the performance and practicality of the either materials from surgeon's personal opinion.

  within 24 hours after surgery

Study Arms (2)

Sternum Guard

EXPERIMENTAL

The treatment of interest was Sternum GuardTM application during sternotomy.

Other: Sternum Guard

Bone wax

ACTIVE COMPARATOR

The 'bone wax' arm was the control group of active comparator as the widely-used materials during sternotomy.

Other: Bone Wax

Interventions

Sternum Guard OTHER

The intervention being assessed is a surgical drape used as a cover of sternal bones and the neighboring structures exposed during median sternotomy named Sternum Guard. Sternum guard® is a single use, sterile surgical drape with modified cellulose designed specifically to reduce the risk of surgical site infection (SSI). It is made of 4 parts, the main part is in contact with the retractors and the sternum edge. It is made of carboxymethylated cellulose (CMC) spunlace which makes direct contact with the sternum edges. It contributes to blood absorption, to decreasing of pH environment, and to haemostatic action through a physical effect (compression); another part was made from hydrophilic spunbond (swabs) allowing blood absorption, comfort and protection

Also known as: Sternum GuardTM, Vygon, Netherlands, product code 40.90.11

Sternum Guard

Bone Wax OTHER

patients in this group were given Bone Wax as the hemostatic material during sternotomy. Midline sternotomy with an oscillating saw was conducted after standard aseptic surgical techniques. Bone wax was applied to both spongiosa surfaces of resected sternal bones until bleeding had ceased.

Also known as: Bone Wax, Braun Aesculap AG & CO. KG, Duisburg, Germany

Bone wax

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ages \> 18 years old
• Patients who are scheduled electively for cardiac surgery
• Cardiac surgery with the usage of cardiopulmonary bypass machine
• Patients who are agreed to participate in this study

You may not qualify if:

• Patients who are scheduled for surgery in emergency or urgent manner
• Patients with the history of uncontrolled hypertension and uncontrolled diabetes mellitus.
• Patients with the history of past cardiac surgery
• Drop - out Criteria:
• Patients who are pronounced death on operation table
• Patients who are pronounced death within hospitalization
• Patients who are lost to follow up (Day 30 post-operative)
• Patients who are not committed for the whole stage of the research

Sponsors & Collaborators

• Indonesia University: lead
• Vygon GmbH & Co. KG: collaborator

Study Sites (1)

National Cardiovascular Center Harapan Kita

Jakarta, DKI Jakarta, 11410, Indonesia

Location

Related Publications (4)

• Ohta S, Nishiyama T, Sakoda M, Machioka K, Fuke M, Ichimura S, Inagaki F, Shimizu A, Hasegawa K, Kokudo N, Kaneko M, Yatomi Y, Ito T. Development of carboxymethyl cellulose nonwoven sheet as a novel hemostatic agent. J Biosci Bioeng. 2015 Jun;119(6):718-23. doi: 10.1016/j.jbiosc.2014.10.026. Epub 2014 Dec 3.

  PMID: 25488042 RESULT

• Lewis KM, Spazierer D, Urban MD, Lin L, Redl H, Goppelt A. Comparison of regenerated and non-regenerated oxidized cellulose hemostatic agents. Eur Surg. 2013;45(4):213-220. doi: 10.1007/s10353-013-0222-z. Epub 2013 Jul 4.

  PMID: 23950762 RESULT

• Schonauer C, Tessitore E, Barbagallo G, Albanese V, Moraci A. The use of local agents: bone wax, gelatin, collagen, oxidized cellulose. Eur Spine J. 2004 Oct;13 Suppl 1(Suppl 1):S89-96. doi: 10.1007/s00586-004-0727-z. Epub 2004 Jun 22.

  PMID: 15221572 RESULT

• Liu Z, Dumville JC, Norman G, Westby MJ, Blazeby J, McFarlane E, Welton NJ, O'Connor L, Cawthorne J, George RP, Crosbie EJ, Rithalia AD, Cheng HY. Intraoperative interventions for preventing surgical site infection: an overview of Cochrane Reviews. Cochrane Database Syst Rev. 2018 Feb 6;2(2):CD012653. doi: 10.1002/14651858.CD012653.pub2.

  PMID: 29406579 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases; Surgical Wound Infection; Postoperative Hemorrhage

Interventions

bone wax

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage

Study Officials

• Komite Etik of National Cardiovascular Center Harapan Kita

  Ethical Committee of National Cardiovascular Center Harapan Kita

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects/participants were not aware of the arms/treatment given as they were under general anesthesia during the application of interventions being studied. Besides, during the informed consent for the elective sternotomy procedure, subjects were extensively given explanation of the purpose, methods, benefits and risks of the procedure including the randomized nature of the allocation to either arms of the study. Principal investigators as well as outcomes assessor were kept unaware of the randomization of interventions as they both were restricted for assessing the patients' medical record and the patient identity were coded in the primary database.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A single-blind, single center, parallel phase 4 randomized clinical trial was conducted with two intervention arms: an intervention arm with the use of Sternum GuardTM and a control arm with the use of bone wax in which the subjects' recruitment and treatment were conducted simultaneously by means of a block randomization.

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: February 8, 2022
• Study Start: May 17, 2020
• Primary Completion: October 8, 2021
• Study Completion: October 30, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: November 30, 2021 for 2 (two) years
• Access Criteria: for peer-reviewing or for further analysis or when needed by authors of a systematic review/meta analysis of randomized controlled trials

Locations

ID (1)